Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

NCT01995890 | Completed Phase 4 DMC

• 1 other identifier: TVPEI
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

The Nevanac product information insert says that it can cause increase in eye pressure in 5-10% of patients. There is very little published literature on the effect of topical Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report this effect with a working hypothesis that there is no increase in eye pressure following use of Nepafenac eye drops.

Conditions

Intraocular Pressure

Keywords

nepafenac eye drops; intraocular pressure

Outcome Measures

Primary Outcomes (2)

• Intraocular pressure

  Intraocular pressure elevation of more than 4 mmHg from baseline

  4 weeks

• Intraocular pressure

  Intraocular pressure elevation of more than 4 mmHg from baseline

  8 weeks

Study Arms (2)

nepafenac

EXPERIMENTAL

Nepafenac 0.1% eye drops, 3 times a day

Drug: nepafenac

control

NO INTERVENTION

No intervention in the control arm

Interventions

nepafenac DRUG

Also known as: Nevanac

nepafenac

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Best corrected visual acuity better than 20/80 in both eyes
• Intraocular pressure ≤21 mmHg in both eyes
• Open angles on 4 mirror gonioscopy without indentation
• Normal optic disc on stereoscopic examination and photographs

You may not qualify if:

• Change in the systemic medication profile during the course of the study
• Allergy to nepafenac molecule
• Corneal thinning/corneal infections
• Any intraocular surgery in past 3 months
• Pregnancy or those planning to conceive
• Breast feeding patients
• Unwillingness to participate in the trial
• Concomitant use of any other ocular drug (except artificial tears)

Sponsors & Collaborators

• Dr T V Patel Eye Institute: lead

Study Sites (1)

Dr TV Patel Eye Insititute

Vadodara, Gujarat, 390001, India

Location

Related Publications (3)

• Gamache DA, Graff G, Brady MT, Spellman JM, Yanni JM. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: I. Assessment of anti-inflammatory efficacy. Inflammation. 2000 Aug;24(4):357-70. doi: 10.1023/a:1007049015148.

  PMID: 10850857 BACKGROUND

• Chiba T, Kashiwagi K, Chiba N, Tsukahara S. Effect of non-steroidal anti-inflammatory ophthalmic solution on intraocular pressure reduction by latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2006 Mar;90(3):314-7. doi: 10.1136/bjo.2005.080895.

  PMID: 16488953 RESULT

• Warren KA, Fox JE. Topical nepafenac as an alternate treatment for cystoid macular edema in steroid responsive patients. Retina. 2008 Nov-Dec;28(10):1427-34. doi: 10.1097/IAE.0b013e31817e7ead.

  PMID: 18664937 RESULT

MeSH Terms

Interventions

nepafenac

Study Officials

• Paaraj R Dave, MD

  TV Patel Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

IN (1)